Zantac Tablets 150mg

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

RANITIDINE

Verfügbar ab:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC-Code:

A02BA02

INN (Internationale Bezeichnung):

RANITIDINE 150 mg

Darreichungsform:

TABLET

Zusammensetzung:

RANITIDINE 150 mg

Verschreibungstyp:

POM

Therapiebereich:

DRUGS FOR ACID RELATED DISORDERS

Berechtigungsstatus:

Suspended

Berechtigungsdatum:

2006-09-18

Gebrauchsinformation

LOGO GSK
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC
® 150 MG FILM COATED TABLETS
RANITIDINE (AS HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Zantac is and what it is used for
2
What you need to know before you take Zantac
3
How to take Zantac Tablets
4
Possible side effects
5
How to store Zantac
6
Contents of the pack and other information
1
WHAT ZANTAC IS AND WHAT IT IS USED FOR
Zantac contains a medicine called ranitidine. This belongs to a group
of medicines
called H
2
-receptor antagonists. It lowers the amount of acid in your stomach.
FOR ADULTS (INCLUDING THE ELDERLY) Zantac is used to:
•
treat ulcers in the stomach, or the part of the gut it empties into
(the duodenum)
•
prevent stomach ulcers when they are a side effect of some medicines
•
treat problems caused by acid in the food pipe (oesophagus) or too
much acid in
the stomach. Both of these can cause pain or discomfort sometimes
known as
‘indigestion’, ‘dyspepsia’ or ‘heartburn’
•
treat other conditions where reduction of acid in the stomach is
likely to be
beneficial
•
treat Zollinger-Ellison syndrome – a condition in which there is
increased
production of the hormone gastrin
FOR CHILDREN (3 TO 18 YEARS) Zantac is used to:
•
treat ulcers in the stomach, or the part of the gut it empties into
(the duodenum)
•
treat problems caused by acid in the food pipe (oesophagus) or too
much acid in
the stomach. Both of these can cause pain or discomfort sometimes
known as
“indigestio

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zantac 150 mg Film-Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of ranitidine as ranitidine
(as hydrochloride).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White round tablets engraved 'GXEC2' on one side and plain on the
other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of duodenal ulcer and benign gastric ulcer including
that associated with non-
steroidal
anti-inflammatory
agents.
Prevention
of
non-steroidal
anti-inflammatory
drug
(including aspirin) associated duodenal ulcers, especially in patients
with a history of peptic
ulcer disease. Zantac Tablets are also indicated for treatment of
post-operative ulcer, reflux
oesophagitis, Zollinger-Ellison syndrome and other conditions where
reduction of gastric acid
secretion is likely to be beneficial.
CHILDREN (3 TO 18 YEARS)
•
Short term treatment of peptic ulcer
•
Treatment of gastro-oesophageal reflux, including reflux oesophagitis
and symptomatic
relief of gastro-oesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS (INCLUDING THE ELDERLY) / ADOLESCENTS (12 YEARS AND OVER)
The usual initial dosage in duodenal and benign gastric ulcer is 150
mg twice daily or 300 mg
at night. This may be increased to ranitidine 300 mg twice daily
without an increased incidence
of unwanted effects. Subsequently a maintenance dose of 150mg at night
may be used.
Smoking is associated with a higher rate of ulcer relapse, and such
patients should be advised
to stop smoking. In those who fail to comply with such advice, a dose
of 300 mg at night
provides additional therapeutic benefit over the standard dose.
In most cases of duodenal ulcer, benign gastric ulcer and post
operative ulcer, healing occurs
within 4 weeks. Healing usually occurs after a further 4 weeks in
those not fully healed after
the initial 4 weeks. In ulcers following non-steroid